Trial Outcomes & Findings for Nicotine Administration and Post-operative Opioid Use With Bariatric Surgery (NCT NCT01194089)

Results Overview

Opioid use was calculated in intravenous morphine equivalents (iv MEQ) according to the Mayo Clinic Pharmacy opioid conversion calculator based on the recommendations from the American Pain Society. Specifically, the following conversion was used: 10 mg in MEQ=100mcg iv fentanyl=1.5 mg iv hydromorphone=20mg oral oxycodone=30mg oral hydrocodone.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

95 participants

Primary outcome timeframe

During PACU stay (approximately 94 minutes after operation), 24 hours after operation

Results posted on

2015-07-09

Participant Flow

Subjects were enrolled at Mayo Clinic in Rochester, Minnesota from August 2010 to March 2014.

95 subjects randomized; 48 to Placebo arm, and 47 to Nicotine arm. On the Placebo arm one subject had their surgery rescheduled and did not take part in the study, leaving 47 starting. On the Nicotine arm 3 subjects withdrew consent prior to surgery and 1 subject's surgery was cancelled, and 1 subject surgery rescheduled, leaving 42 starting.

Participant milestones

Participant milestones
Measure	Nasal Nicotine Spray 3 mg of nasal nicotine will be administered postoperatively.	Nasal Normal Saline Spray 1 ml of nasal normal saline spray will be administered postoperatively.
Overall Study STARTED	42	47
Overall Study COMPLETED	42	47
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nicotine Administration and Post-operative Opioid Use With Bariatric Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nasal Nicotine Spray n=42 Participants 3 mg of nasal nicotine will be administered postoperatively.	Nasal Normal Saline Spray n=47 Participants 1 ml of nasal normal saline spray will be administered postoperatively.	Total n=89 Participants Total of all reporting groups
Age, Continuous	46.0 years STANDARD_DEVIATION 9.1 • n=5 Participants	44.9 years STANDARD_DEVIATION 10.6 • n=7 Participants	45.8 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	47 Participants n=7 Participants	89 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants	47 participants n=7 Participants	89 participants n=5 Participants

PRIMARY outcome

Timeframe: During PACU stay (approximately 94 minutes after operation), 24 hours after operation

Opioid use was calculated in intravenous morphine equivalents (iv MEQ) according to the Mayo Clinic Pharmacy opioid conversion calculator based on the recommendations from the American Pain Society. Specifically, the following conversion was used: 10 mg in MEQ=100mcg iv fentanyl=1.5 mg iv hydromorphone=20mg oral oxycodone=30mg oral hydrocodone.

Outcome measures

Outcome measures
Measure	Nasal Nicotine Spray n=42 Participants 3 mg of nasal nicotine will be administered postoperatively.	Nasal Normal Saline Spray n=47 Participants 1 ml of nasal normal saline spray will be administered postoperatively.
Postoperative Opioid Use During the Postanesthesia Care Unit (PACU) Stay, and the First 24 Hours Postoperatively During the PACU stay	5.3 mg Interval 0.0 to 10.0	5.2 mg Interval 0.0 to 12.7
Postoperative Opioid Use During the Postanesthesia Care Unit (PACU) Stay, and the First 24 Hours Postoperatively First 24 hours postoperatively	39.6 mg Interval 20.0 to 52.5	32.7 mg Interval 20.3 to 51.3

SECONDARY outcome

Timeframe: 24 hours postoperatively.

Rescue antiemetic therapy was 0.625 mg droperidol. Recalcitrant postoperative pain, nausea and vomiting (PONV) was treated per discretion of the supervising anesthesiologist.

Outcome measures

Outcome measures
Measure	Nasal Nicotine Spray n=42 Participants 3 mg of nasal nicotine will be administered postoperatively.	Nasal Normal Saline Spray n=47 Participants 1 ml of nasal normal saline spray will be administered postoperatively.
Number of Participants Who Needed to Use Antiemetic Medication in the PACU	24 participants	12 participants

SECONDARY outcome

Timeframe: on admission, 30 minutes, 60 minutes, at discharge

Population: Not all participants completed the pain scale at every time point. The participants analyzed per arm (nicotine, normal) at each time point were: on admission (40, 45); 30 minutes (40, 47); 60 minutes (34, 40); at discharge (39, 44),

Upon arrival in the PACU and at least every 30 minutes thereafter while in the PACU, the subject was asked to report pain using a numerical pain score for current pain at rest from 0 (representing no pain) to 10 (representing the worst imaginable pain).

Outcome measures

Outcome measures
Measure	Nasal Nicotine Spray n=40 Participants 3 mg of nasal nicotine will be administered postoperatively.	Nasal Normal Saline Spray n=47 Participants 1 ml of nasal normal saline spray will be administered postoperatively.
Numeric Pain Score At discharge	3 units on a scale Interval 2.0 to 4.0	3 units on a scale Interval 2.0 to 4.0
Numeric Pain Score On admission	0 units on a scale Interval 0.0 to 6.0	3 units on a scale Interval 0.0 to 6.0
Numeric Pain Score 30 minutes	5 units on a scale Interval 0.5 to 6.0	5 units on a scale Interval 0.0 to 7.0
Numeric Pain Score 60 minutes	4 units on a scale Interval 2.0 to 6.0	4 units on a scale Interval 3.0 to 5.0

Adverse Events

Nasal Nicotine Spray

Serious events: 2 serious events

Other events: 28 other events

Deaths: 0 deaths

Nasal Normal Saline Spray

Serious events: 1 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Nasal Nicotine Spray n=42 participants at risk 3 mg of nasal nicotine will be administered postoperatively.	Nasal Normal Saline Spray n=47 participants at risk 1 ml of nasal normal saline spray will be administered postoperatively.
Surgical and medical procedures Anastomotic leak	2.4% 1/42 • Number of events 1	0.00% 0/47
Gastrointestinal disorders Readmission for postoperative pain, nausea, and vomiting	0.00% 0/42	2.1% 1/47 • Number of events 1
Blood and lymphatic system disorders Blood transfusion	2.4% 1/42 • Number of events 1	0.00% 0/47

Other adverse events

Other adverse events
Measure	Nasal Nicotine Spray n=42 participants at risk 3 mg of nasal nicotine will be administered postoperatively.	Nasal Normal Saline Spray n=47 participants at risk 1 ml of nasal normal saline spray will be administered postoperatively.
Gastrointestinal disorders Postoperative pain, nausea, and vomiting (PONV)	64.3% 27/42 • Number of events 27	51.1% 24/47 • Number of events 24
Respiratory, thoracic and mediastinal disorders Nasal burning	2.4% 1/42 • Number of events 1	0.00% 0/47

Additional Information

Dr. Toby N. Weingarten

Mayo Clinic

Phone: 507-255-1612

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place